Point to Consider While Apply for Market Licenses in Asia Pacific Region

This webinar will explain how pharmaceuticals are regulated in Asia Pacific region, the different guidelines for registering the drugs, requirements to maintain the registrations, etc.

Why Should You Attend:

Most countries in the Asia Pacific have developed the regulations for pharmaceutical products (exported from foreign markets) and have made major changes in the regulations in recent years.

When applying for global marketing approval and launch in different regions, we should develop a clear regulatory strategy by evaluating different regulatory regulations, patent terms, data exclusivities, application routes, data requirements, and timeline. A good strategy can eliminate unnecessary studies, minimize the delay in drug approvals, speed up the product launch, and reduce overall cost.

This webinar will look at the registration process and requirements in the Asia Pacific region.

Areas Covered in the Webinar:

• The world pharmaceutical industry division based on the region, development strategy, regulations and marketing interest.
• Regulatory intelligence and strategy
• Registration pathways
• Registration dossier and data requirements
• GMP requirements for registration
• Manage the pre-approval inspections

Who Will Benefit:

• Regulatory Affairs Personnel
• Pharmaceutical Development Personnel
• Managements
• Compliance Professionals

Instructor Profile:

Dr. Linda Yang, was until recently Associate Director, Regulatory Affairs for a big pharmaceutical company. Currently as an independent consultant, provides directions for regulatory strategy, regulatory submission, and emerging markets regulatory management.

Dr. Yang spent last 20 years working for pharmaceutical companies and is an expert in regulatory and quality compliance. She has broad background and played leadership role in functional areas such as product development, business process optimization, quality compliance, clinical development, and regulatory strategy. She had hands on experience on global regulatory management and submission.

She has experience working with US, European and other global regulatory regulations. She co-authored the book of the Fundamentals of US Regulatory Affairs (2009 and 2013). She currently teaches regulatory affairs and compliance for University of Berkeley Extension.

Dr. Yang obtained her Ph.D in 1992; MBA in 2004; Certifications of Regulatory Affairs (RAC) and Quality Auditor (CQA) in 2009.